FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline
    Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline

    Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.

  • Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation
    Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation

    Shipping and its validation are too often underappreciated in pharmaceutical quality systems (PQS), which can hide risk and uncertainty in the supply chain. A line-of-sight (LOS) approach to shipping validation brings focus to risks in transportation, and rouses quality improvement opportunities throughout the PQS. An LOS approach begins with the end in mind — connecting product critical quality attributes (CQAs) to integrity of the cold chain and to shipping validation design.

  • Is Blow-Fill-Seal Right For Your Aseptic Filling Operation?
    Is Blow-Fill-Seal Right For Your Aseptic Filling Operation?

    United Therapeutics discusses how it uses BFS in its production, the biggest barriers to further industry adoption of the technology, and how recent guidance documents — and a new PDA Technical Report — are helping pharma companies better address challenges and reap the benefits of BFS in their operations.

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PHARMA OUTSOURCING WHITE PAPERS

Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions

Flavivirus vaccine development and production constitute many challenges and can be both space- and resource-consuming. This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production. Single-use production bioreactors and chromatography purification columns mitigate cross-contamination risk and support increased operator safety, while reducing time to market by eliminating costly and time-consuming cleaning operations.

Managing Risk In Biomanufacturing Managing Risk In Biomanufacturing

Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

The Future of BioManufacturing

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Customizing The Cold Chain

With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.

Four Reasons For The Rise In Blister Packaging

Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Sharing Instruments: Bottleneck Or Increasing Utilization?

Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.

Driving Productivity In Protein Purification

Crucial to the successful operation of any research laboratory is the ability to efficiently generate purified proteins for further investigation and analysis. By Per Lidén (GE Healthcare Life Sciences), Svend Kjær (Cancer Research UK) and Mark Cooper (Abcam)

How A Big Pharma Company Quickly Transferred 2 Oral Powder Antibiotics To Another Facility

Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.

Vertex Pharmaceuticals: Document Management Strategies For R&D

Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

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INDUSTRY INSIGHTS

  • Future-Proofing Your Single-Use Biomanufacturing Capacity
    Future-Proofing Your Single-Use Biomanufacturing Capacity

    The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.

  • End-to-end Technology Transfer Services In Oral Solids And Sterile
    End-to-end Technology Transfer Services In Oral Solids And Sterile

    In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.

  • Demand Led Supply Chain Approach Gets Medications To Clinical Sites Quickly
    Demand Led Supply Chain Approach Gets Medications To Clinical Sites Quickly

    An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy.

  • Consultants’ Guide To Flexible Biomanufacturing Solutions
    Consultants’ Guide To Flexible Biomanufacturing Solutions

    Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.

  • Important Considerations When Sourcing Reference Products For Biosimilar Studies
    Important Considerations When Sourcing Reference Products For Biosimilar Studies

    Pharmaceutical companies face a number of challenges when sourcing comparator compounds for clinical trials, including addressing product lead times, availability, expiry limitations, safety or cost. Learn how clinical trial sponsors can determine the best strategy to meet these challenges.

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OUTSOURCING EVENTS

Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and Suggestions July 11, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Manufacturing & Laboratory Equipment Qualification – Ensuring Bullet-Proof Results July 12, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA Guidance on Medical Device Cybersecurity - Preparing for the Present and Future July 18, 2017
1pm-2:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
CRO Oversight Post ICH GCP E6 (R2) Addendum July 24, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
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